Multi-modal Imaging of Myofascial Pain
Purpose
The goal of this study is to develop new imaging biomarkers for quantitative assessments of myofascial pain.
Condition
- Myofascial Pain
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Absence of a history of chronic pain in the targeted anatomical location (i.e., neck and shoulder) that had limited activities of daily living or work 2. A numerical current pain index of lower than 0.5 according to initial assessment with visual analog scale 3. Able to understand the goal of the project and give informed consent. Healthy Volunteer
Exclusion Criteria
- Pregnancy or breastfeeding 2. Contraindication to MRI 3. Previous severe/acute neck or shoulder injury 4. Previous neck or shoulder surgery 5. Neck or shoulder deformities 6. Inability to provide consent. Myofascial Pain Patient Inclusion Criteria: 1. Between the ages of 18 and 80 years old 2. Neck and/or shoulder pain, unilateral or bilateral 3. Duration of symptoms for longer than 4 weeks 4. Pain scale at the active state higher than 4 according to initial assessment with visual analog scale 5. Presence of active trigger point(s) according to palpation and/or presence of taut band Myofascial Pain Patient Exclusion Criteria: 1. Recent history of trauma to the neck (e.g., whiplash) 2. Acute cervical radiculopathy 3. Acute cervical spine pain component or acute cervical spinal pathology Presence of neuromuscular pathologies or inflammatory muscle diseases (e.g., dermatomyositis) 4. Systemic disease with diffuse body pain (e.g., system lupus erythematosus and and thyroid disease) 5. Peripheral neuropathy 6. Cancer-related pain 7. Pregnancy, coagulopathy, fever, general/local infection at the pain site, substance abuse, peripheral neuropathy, or any other diseases that may account for signs and symptoms mimicking myofascial pain 8. Contraindication to MRI.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- This is a two-phase, NIH-supported study. The first R61 phase (currently awarded) is an observational study with one control group and one patient group. The second R33 phase is a randomized clinical trial, which will be awarded by the end of the R61 phase. The study design provided here is for R61 only.
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Multi-modal imaging of myofascial pain |
Participants with and without myofascial-related pain disease will receive multi-modal, multi-parametric, multi-scale imaging, including magnetic resonance imaging, surface electromyography, and fiber-optic imaging and sensing. |
|
Recruiting Locations
Washington University in St. Louis and nearby locations
St Louis 4407066, Missouri 4398678 63110
More Details
- NCT ID
- NCT06036524
- Status
- Recruiting
- Sponsor
- Washington University School of Medicine
Detailed Description
This study aims to develop a multi-modal, multi-parametric, multi-scale imaging of the human myofascial unit by combining magnetic resonance imaging (MRI), surface electromyography (sEMG), and fiber-optic imaging and sensing. Participants (half with active neck/shoulder/back pain, and half healthy controls) will be recruited from pain management clinics and Volunteer for Health, or will be referred by Dr. Xioabin Yi. They will undergo all three imaging techniques and complete a number of patient questionnaires over the course of a single study visit. The study team will then identify candidate biomarkers capable of differentiating between healthy (no myofascial pain) and those with active pain to target in a future clinical trial.